Logo: to the web site of Uppsala University

Objectives

To estimate how many people object to storage of biological samples collected in health care in Sweden and to their use in research and how many withdraw previous consent.

Design

Cross sectional study of register data.

Setting

Biobanks used in Swedish health care, 2005-6.

Population

Data on refusal to consent were obtained for 1.4 million biobank samples per year from 20 of 21 counties.

Main outcome measures

Rates of preliminary refusal to consent, confirmed refusal, and withdrawal of consent.

Results

Patients refused consent to either storage or use of their samples in about 1 in 690 cases, about 1 in 1600 confirmed their decision by completing a dissent form. Rather than having the samples destroyed, about 1 in 6200 patients wanted to restrict their use. Of those who had previously consented, about 1 in 19 000 withdrew their consent.

Conclusions

Refusal to consent to biobank research in Sweden is rare, and the interests of individuals and research interests need not be at odds. The Swedish healthcare organisation is currently obliged to obtain either consent or refusal to each potential use of each sample taken, and tack of consent to research is used as the default position. A system of presumed consent with straightforward opt out;would correspond with people's attitudes, as expressed in their actions, towards biobank research.

In the debate on biobank regulation, arguments often draw upon findings in surveys on public attitudes. However, surveys on willingness to participate in research may not always predict actual participation rates. We compared hypothetical willingness as estimated in 11 surveys conducted in Sweden, Iceland, United Kingdom, Ireland, United States and Singapore to factual participation rates in 12 biobank studies. Studies were matched by country and approximate time frame. Of 22 pairwise comparisons, 12 suggest that factual willingness to participate in biobank research is greater than hypothetical, six indicate the converse relationship, and four are inconclusive. Factual donors, in particular when recruited in health care or otherwise face-to-face with the researcher, are possibly motivated by factors that are less influential in a hypothetical context, such as altruism, trust, and sense of duty. The value of surveys in assessing factual willingness may thus be limited.

In Sweden, most patients are recruited into biobank research by non-researcher doctors. Patients’ trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients’ mistaken trust. There are at least three kinds of mistaken trust, each of which requires a different set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient’s reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good.

Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents, overseeing bodies, and formal procedures. The process of institutionalising distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure public trust. This paper examines some limitations of this approach. First, past atrocities cannot provide the necessary justification unless institutionalised distrust is a necessary or efficient means to prevent future ones; and there are several reasons to doubt that this is the case. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers—the kinds of qualities that institutionalised distrust calls into question. Third, ethics guidelines cannot, as it is sometimes assumed, educate or guide researchers to moral behaviour unless they already have considerable capacity for moral judgment. Fourth, institutionalised distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics as a pursuable activity. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences of allowing their moral competence to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and not obstructed from doing so.